All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
To share this seminar info with your colleagues,
click here.

Online audio seminar 341

Auditing QC Laboratories for FDA
Compliance

Learn how to use internal audits in
preparation for regulatory inspections

Recorded, available with all reference material
at any time

Quality control laboratories are considered high risk because after testing and
approval pharmaceutical drug products and APIs are released to the market
without further check. That's the reason why FDA and other agencies put highest
emphasis on inspections of QC laboratories. The large number of recent QC
related 483's and warning letters prove that companies have issues to comply
with regulations. Auditing laboratories is an ideal tool to verify compliance of
laboratory practices with regulations and to prepare your organization for
regulatory inspections.

Key Questions related to audits of QC laboratories are:

How frequently should laboratories be audited?

Who should be the members of the audit team?

What does FDA require: Vertical or horizontal audits?

How to prepare for an audit?

How to conduct an 'FDA-inspection like' audit?

How to audit the laboratory quality system?

What are most frequently found FDA inspectional observations

What documents should be audited?

How to audit a laboratory quality system?

How to respond to audit reports with deviations

What are critical questions for sampling, sample handling,
validation, testing, reporting and archiving of data?

How to effectively follow up to continually improve the
laboratory system?

How to write an FDA compliant audit report?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations and examples.
After the seminar, an extensive list of reference material like
SOPs, worksheets, templates and examples will help immediate and
cost effective implementation.

During the interactive presentation you learn about:

Why are internal audits important

FDA and international requirements for laboratory audits

FDA and EMA inspections as models for laboratory audits

Developing an SOP for 'FDA Inspection Like' audits

Developing an audit schedule

The audit team: members, tasks, responsibilities

Most critical audit areas based on risk assessment

Looking at the right documentation

Auditing the laboratory quality system

Audit items along the sample and data workflow from sampling
to record archiving

Assessment through laboratory walkthrough

The importance of the exit meeting

Writing the audit report

Follow-up with corrective and preventive actions: Going
through six case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

Audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.